Systems and methods for providing arrhythmia therapy in mri environments

ABSTRACT

Systems and methods for arrhythmia therapy in MRI environments are disclosed. Various systems disclosed utilize ATP therapy rather than ventricular shocks when patients are subjected to electromagnetic fields in an MRI scanner bore and shock therapy is not available. As the patient is moved out from within the scanner bore and away from the MRI scanner, the magnetic fields diminish in strength eventually allowing a high voltage capacitor within the IMD to charge if necessary. The system may detect when the electromagnetic fields no longer interfere with the shock therapy and will transition the IMD back to a normal operational mode where shock therapy can be delivered. Then, if the arrhythmia still exists, the system will carry out all of the system&#39;s prescribed operations, including the delivery of electric shocks to treat the arrhythmia.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/639,848, filed on Dec. 16, 2009, which claims the benefit of U.S.Provisional Application No. 61/153,708, filed on Feb. 19, 2009, each ofwhich is hereby incorporated by reference for all purposes in itsentirety.

TECHNICAL FIELD

Various embodiments of the present invention generally relate toimplantable medical devices. More specifically, embodiments of thepresent invention relate to systems and methods for providing arrhythmiatherapy in MRI environments.

BACKGROUND

When functioning properly, the human heart maintains its own intrinsicrhythm and is capable of pumping adequate blood throughout the body'scirculatory system. However, some individuals have irregular cardiacrhythms, referred to as cardiac arrhythmias, which can result indiminished blood circulation and cardiac output. One manner of treatingcardiac arrhythmias includes the use of a pulse generator such as apacemaker, an implantable cardiac defibrillator, or a cardiacresynchronization (CRT) device. Such devices are typically coupled to anumber of conductive leads having one or more electrodes that can beused to deliver pacing therapy and/or electrical shocks to the heart. Inatrioventricular (AV) pacing, for example, the leads are usuallypositioned in a ventricle and atrium of the heart, and are attached vialead terminal pins to a pacemaker or defibrillator which is implantedpectorally or in the abdomen.

Magnetic resonance imaging (MRI) is a non-invasive imaging procedurethat utilizes nuclear magnetic resonance techniques to render imageswithin a patient's body. Typically, MRI systems employ the use of amagnetic coil having a magnetic field strength of between about 0.2 to 3Teslas. During the procedure, the body tissue is briefly exposed to RFpulses of electromagnetic energy in a plane perpendicular to themagnetic field. The resultant electromagnetic energy from these pulsescan be used to image the body tissue by measuring the relaxationproperties of the excited atomic nuclei in the tissue.

During imaging, the electromagnetic radiation produced by the MRI systemmay interfere with the operation of the pulse generator and leads. Insome cases, for example, the presence of strong magnetic fields and RFenergy during an MRI scan may prevent the charging of a high voltagecapacitor within the pulse generator, which can affect the ability ofthe pulse generator to deliver electrical shocks to the patient when anevent such as a tachyarrhythmia occurs. In other cases, the RF energyand/or time varying gradient fields may prevent the sensing anddetection of tachyarrhythmias.

SUMMARY

Various embodiments of the present invention generally relate toimplantable medical devices (IMD). More specifically, embodiments of thepresent invention relate to systems and methods for providing arrhythmiatherapy in MRI environments.

Some embodiments provide for a method of operating an IMD in thepresence of an MRI environment or other environment with strongelectromagnetic fields. According to various embodiments, the IMD iscapable of operating in a variety of operational modes. Examples ofoperational modes include, but are not limited to, a normal mode, atachy therapy mode, an MRI mode, an MRI mode stat therapy state, and anantitachyarrhythmia therapy pacing (ATP) mode.

When a patient with an IMD enters the presence of an MRI environment,the IMD is placed from its normal operation mode into a firstoperational mode (e.g., an MRI mode), which adjusts one or more settingswithin the IMD to adjust the operation of the IMD when exposed to an MRIelectromagnetic field. In some embodiments, the transition from thenormal operation mode to the first operational mode may cause the IMD todeactivate one or more sensors, or alternatively, to ignore the signalsreceived from the sensors, which are normally used to sense variouselectrical parameters within the body. According to various embodiments,the IMD can be placed in the first operational mode in response to acommand received from an external device.

In some embodiments, the IMD automatically detects the presence of theelectromagnetic fields that would saturate the power supplyferromagnetic components resulting in an inability of the IMD to chargethe high voltage capacitor to a sufficient level for delivering shocktherapy before a maximum charging time has been reached. In someembodiments, a core saturation signal is generated (e.g., internallyand/or externally to the IMD) to indicate the presences of anelectromagnetic field that would saturate the power supply ferromagneticcomponents. The IMD can monitor for the core saturation signal andinitiate a transition to the first operational mode automatically.

In various embodiments of the first operational mode, one or moresensors are deactivated or the inputs from those sensors are ignored. Inthis mode, an operator operating the MRI scanner monitors the patientfor potential distress within the scanner. If the operator determinesthat the patient is in distress, then the operator stops the MRI anduses an external device, such as a programmer, a device communicator, anMRI communicator, an MRI partner, a personal computer with a telemetrydevice, an MRI scanner controller with a telemetry device, or otherdevice to transmit a command (e.g., a stat therapy command) to the IMDindicating the need to provide immediate therapy to the patient from theIMD.

A device communicator, for example, can be an external device that linksimplanted devices with one or more patient management systems. Accordingto some embodiments, the device communicator is an electronic devicethat uses RF to interrogate the implanted PG on either a scheduled basisor ad hoc basis and then transmits the retrieved information to thepatient management system that collects, processes and reports on theretrieved information to physicians.

According to some embodiments, the command can be received from theexternal device using RF, acoustic, or other wireless communicationswhile the IMD is operating in a first operational mode (e.g., an MRImode). Once the command is received by the IMD, the IMD then enters asecond operational mode (e.g., an MRI mode stat therapy state). In someembodiments, upon entering the second operational mode one or moresensors associated with the IMD are reactivated. In those embodimentswhere the sensors are not deactivated during the first operational mode,the IMD no longer ignores signals from the sensors. Using the input fromthe sensors, the IMD determines whether a tachyarrhythmia or othercardiac episode or condition is present.

If during the second operation mode the IMD determines that notachyarrhythmia is present, the IMD is configured to return to the firstoperational mode, and in some embodiments deactivates the one or moresensors or, alternatively, ignores the signals received from thesensors. If, however, a tachyarrhythmia is present, then the IMD can beconfigured to deliver antitachyarrhythmia pacing (ATP) therapy to thepatient. In some embodiments, the ATP therapy may start with higherpacing rates in earlier programmed intervals and decreasing pacing ratesin subsequent intervals. In accordance with various embodiments, only amaximum number of ATP sessions (e.g., two sessions, three sessions, foursessions, five sessions, etc.) will be delivered in the secondoperational mode.

While delivering ATP therapy, some embodiments of the IMD monitor a coresaturation signal to determine when the IMD is out of the strongmagnetic fields created by the MRI device. Once the IMD is outside ofthe field, the IMD can enter a third operational mode (e.g., a normalmode of operation) where the IMD determines if tachy therapy is needed.If a determination is made that tachy therapy is needed, the IMD mayenter a fourth operational mode (e.g., a tachy therapy mode) to delivershock therapy and/or pacing therapy.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an MRI scanner and an IMD implanted within a torso ofa human patient according to various embodiments;

FIG. 2 is a schematic view of an illustrative pulse generator and leadimplanted within the body of a patient which may be used in accordancewith some embodiments of the present invention;

FIG. 3 is a block diagram illustrating several exemplary components ofan implantable medical device (IMD), such as a pulse generator, inaccordance with one or more embodiments of the present invention;

FIG. 4 is a state flow diagram illustrating exemplary operational modesof an implantable medical device in accordance with various embodimentsof the present invention; and

FIG. 5 is a flow chart illustrating exemplary operations of animplantable medical device in the presence of an MRI environmentaccording to some embodiments of the present invention.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

MRI scanners present complex electromagnetic fields that interfere withtachyarrhythmia detection and therapy. In addition, RF and gradientmagnetic fields present significant electromagnetic energy that canaffect the sense passband of a pulse generator. As a result, during MRIimaging of an individual with an IMD, the electromagnetic radiationproduced by the MRI scanner may interfere with the operation of variouscomponents of an IMD. Consequently, the IMD may be unable todiscriminate cardiac signals from electromagnetic interference (EMI).

For example, electromagnetic radiation is known to affect the operationof pulse generators and leads. In some cases, the presence of strongmagnetic fields, such as a large BO magnetic field and RF energy duringan MRI scan may prevent the charging of a high voltage capacitor withinthe pulse generator by saturating the power supply's ferromagneticcomponents, which can result in an inability to charge the high voltagecapacitor to a stat shock level before a charge timeout occurs.Consequently, the saturation can affect the ability of the pulsegenerator to deliver electrical shocks to the patient when an event suchas a tachyarrhythmia occurs.

Some embodiments provide for a method of operating an IMD in thepresence of an MRI environment. In particular, various embodimentsprovide a way to utilize antitachyarrhythmia pacing (ATP) therapy ratherthan ventricular shocks when the patient is in an MRI scanner bore. Asthe patient is moved away from the scanner, due to the emergency, themagnetic fields (e.g., large BO magnetic fields) diminish in strengtheventually permitting the power supply to recharge the high voltagecapacitor within the IMD, if necessary. Various embodiments of thesystem will detect when the fields no longer interfere with the shocktherapy and will transition the IMD back to a normal operational mode.Then, if the arrhythmia still exists, the IMD will carry out all of thesystem's prescribed operations, including the delivery of shocks ifprogrammed, to treat the arrhythmia.

In the following description, for the purposes of explanation, numerousspecific details are set forth in order to provide a thoroughunderstanding of embodiments of the present invention. It will beapparent, however, to one skilled in the art that embodiments of thepresent invention may be practiced without some of these specificdetails.

While, for convenience, some embodiments are described with reference totreating ventricular tachyarrhythmia using an IMD, embodiments of thepresent invention may be applicable to various other physiologicalmeasurements, treatments, and IMD devices. As such, the applicationsdiscussed herein are not intended to be limiting, but instead exemplary.Other systems, devices, and networks to which embodiments are applicableinclude, but are not limited to, other types of sensory systems, medicaldevices, medical treatments, and computer devices and systems. Inaddition, various embodiments are applicable to all levels of sensorydevices from a single IMD with a sensor to large networks of sensorydevices.

FIG. 1 illustrates a magnetic resonance imaging (MRI) scanner 110 and animplantable medical device (IMD) implanted within a torso of a humanpatient 120 according to various embodiments. One or more externaldevices 130 are capable of communicating with an implantable medicaldevice (IMD) (e.g., a cardiac rhythm management device) implanted withinthe patient 120. In the embodiment shown in FIG. 1, the IMD includes apulse generator (PG) 140 and a lead 150. However, in other embodimentsother components or IMD devices can be used with or without the PG 140and/or lead 150. During normal device operation, the pulse generator 140is configured to deliver electrical therapeutic stimulus to thepatient's heart 160 for providing tachycardia ventricular fibrillation,anti-bradycardia pacing, anti-tachycardia pacing, and/or other types oftherapy.

As illustrated in FIG. 1, the IMD includes a PG 140 such as a pacemaker,a cardiac defibrillator, cardiac resynchronization therapy device, or aneural stimulator. The PG 140 can be implanted pectorally within thebody, typically at a location such as in the patient's chest. In someembodiments, PG 140 can be implanted in or near the abdomen.

The system may also include one or more remote terminals or externaldevices 130 (e.g., a computing device and/or programming device), whichmay communicate with the PG 140 from a location outside of the patient'sbody. According to various embodiments, external device 130 can be anydevice external to the patient's body that is telemetry enabled andcapable of communicating with the IMD 140. Examples of external devicescan include, but are not limited to, programmers (PRM), in-homemonitoring devices, personal computers with telemetry devices, MRIscanner with a telemetry device, manufacturing test equipment, or wands.In some embodiments, the PG 140 communicates with the remote terminal130 via a wireless communication interface. Examples of wirelesscommunication interfaces can include, but are not limited to, radiofrequency (RF), inductive, and acoustic telemetry interfaces.

FIG. 2 is a schematic view of a cardiac rhythm management system 200including an illustrative medical device 140 equipped with a leadimplanted within the body of a patient. In the embodiment depicted,medical device 140 comprises a pulse generator implanted within thebody. The medical device includes a lead 150 placed in the patient'sheart 160. According to various embodiments, lead 150 can be a tachylead. However, in other embodiments, other types of leads can be used.The heart 160 includes a right atrium 210, a right ventricle 220, a leftatrium 230, and a left ventricle 240.

A proximal portion 205 of the lead 150 can be coupled to or formedintegrally with the pulse generator 140. A distal portion 250 of thelead 150, in turn, can be implanted at a desired location within theheart 160 such as in the right ventricle 220, as shown. Although theillustrative embodiment depict only a single lead 150 inserted into thepatient's heart 160, in other embodiments multiple leads can be utilizedso as to electrically stimulate other areas of the heart 160. In someembodiments, for example, the distal portion of a second lead (notshown) may be implanted in the right atrium 210. In addition, or inlieu, another lead may be implanted at the left side of the heart 160(e.g., in the coronary veins, the left ventricle, etc.) to stimulate theleft side of the heart 160. Other types of leads such as epicardialleads may also be utilized in addition to, or in lieu of, the lead 150depicted in FIGS. 1-2.

During operation, the lead 150 can be configured to convey electricalsignals between the heart 160 and the pulse generator 140. For example,in those embodiments where the pulse generator 140 is a pacemaker, thelead 150 can be utilized to deliver electrical therapeutic stimulus forpacing the heart 160. In those embodiments where the pulse generator 140is an implantable cardiac defibrillator, the lead 150 can be utilized todeliver electric shocks to the heart 160 in response to an event such asa ventricular fibrillation. In some embodiments, the pulse generator 140includes both pacing and defibrillation capabilities.

FIG. 3 is a block diagram 300 illustrating several exemplary componentsof an implantable medical device (IMD) 140, such as a pulse generator,in accordance with one or more embodiments. As shown in FIG. 3, IMD 140includes a memory 310, a processor 320, a power supply 330, a sensormodule 340, a communications module 350, a therapy module 360, and astate control module 370. Other embodiments may include some, all, ornone of these modules along with other modules or applicationcomponents. For example, some embodiments may include signal filteringand analysis modules. Still yet, various embodiments may incorporate twoor more of these modules into a single module and/or associate a portionof the functionality of one or more of these modules with a differentmodule. For example, in various embodiments, therapy module 360 andstate control module 370 may be combined into a single control module.

According to various embodiments, pulse generator 140 generates pacingand/or shock pulses and receives electrical signals from the heartthrough lead 150 (or multiple leads) and/or other sensor devices. Powersupply 330 can be any power supplying device that is capable ofproviding the necessary power requirements for the pulse generator 140.In some embodiments, power supply 330 is a battery that may or may notbe rechargeable. In some cases, the battery typically is not capable ofdelivering the short burst of high charge that is required of adefibrillation shock. As such, in various embodiments, the pulsegenerator 140 includes a capacitor (not shown) that charges prior todelivery of a defibrillation shock.

Processor 320 executes instructions stored in the memory 310 or in othermodules such as, e.g., sensor module 340, communications module 350,therapy module 360, state control module 370, and/or other modules thatmay be present. In general, processor 320 executes instructions thatcause the processor 320 to control or facilitate the functions of thepulse generator 140 and/or components of the pulse generator 140. Memory310 can include volatile memory and nonvolatile memory. In accordancewith some embodiments, nonvolatile memory can store code that includesbootstrap functions and device recovery operations, such asmicroprocessor reset. The nonvolatile memory may also includecalibration data and parameter data in some embodiments. The volatilememory can include diagnostic and/or microprocessor-executable code,operating parameters, status data, and/or other data.

In some embodiments, sensor module 340 controls sensory systems andmonitors data received through the sensors and leads 150. For example,the sensor module may monitor electrical signals from an electrode thatcould be provided as part of an electrode on a lead. In someembodiments, the data received can be continuously stored in a circularbuffer in volatile memory which is part of memory 310. Examples of thetype data can include, without limitation, electrogram (EGM) data,marker data, interval data, sensor data, and/or morphology data. Inaccordance with various embodiments, sensor module 340 can usediagnostic data to determine whether various irregular cardiac episodesare occurring. A cardiac episode is any detectable heart condition orbehavior of interest. By way of example, but not limitation, episodessuch as arrhythmias can be detected, either atrial or ventricular,including tachycardia, bradycardia, or fibrillation.

According to the operational mode of the IMD, sensor module 340 mayactivate and/or deactivate one or more sensors or sensory systems. Insome embodiments, sensor module 340 will ignore data received from thesensors when the IMD is in certain operational modes (e.g., MRI mode),as discussed further herein.

Episodes such as tachyarrhythmia can trigger attempts to deliver therapythrough therapy module 360, and also trigger storage of diagnostic datarelated in time to the episodes and the delivery of the therapy. Cardiacepisodes and therapy delivery attempts are both examples of these typesof events. Although embodiments described herein relate to cardiacepisodes, it is to be understood that the invention is not limited tocardiac episodes or events, but may be beneficially applied to othertypes of events and episodes, including, but not limited to, low bloodsugar episodes, neurological episodes, temperature episodes, or others.

In some embodiments, therapy module 360 can deliver pacing therapyand/or shock therapy to restore normal operation of heart 160. Forexample, the pacing therapy can include antitachyarrhythmia pacingtherapy (ATP) for only a limited number of sessions (e.g., a maximum offive sessions). The pacing threshold is generally highest for theinitial session with diminished pacing occurring with each additionalsession.

According to various embodiments, communications module 350 providescommunication functionality so that the IMD 140 can communicate with anexternal device. In some embodiments, communications module 350telemeters requested data to the external device wirelessly using anynumber of suitable wireless communication modes, such as magnetic, radiofrequency, and/or acoustic. As such, through communications module 350,an external device can obtain diagnostic data stored in memory 310, suchas, but not limited to, electrogram (EGM) data, marker data, and therapyadministration data.

In addition to transmitting information, communications module 350,according to various embodiments, monitors for various externalcommands. In some embodiments, the external commands include, but arenot limited to, an MRI mode command, a stat therapy command, a statshock command, and/or the like. When one or more IMD operational modecommands are received, the communications module 350 can transmit thecommand(s) to state control module 370 which will transition between thevarious operational modes.

In accordance with various embodiments, state control module 370 isadapted to place the IMD into one of the following states: a normaloperation mode, a tachy therapy mode, an MRI mode, an MRI mode stattherapy state, and an antitachyarrhythmia therapy (ATP) delivery mode.The transitions between these modes and the IMD operational features aredescribed in more detail in FIG. 4.

FIG. 4 is a state flow diagram 400 illustrating exemplary operationalmodes of an implantable medical device in accordance with variousembodiments. As shown in FIG. 4, when a patient with the IMD enters thepresence of an MRI environment, the IMD is transitioned from a normaloperation mode into an MRI operation mode 420. This can be done in avariety of ways. For example, in some embodiments, an MRI command isreceived from external device 410 through communications module 350. Thecommand is then communicated to state control module 370 which processesthe command and places the IMD in the MRI mode 420. In otherembodiments, an MRI scan can be automatically detected by monitoring fora saturation of the power supply ferromagnetic components created by themagnetic fields of the MRI.

In MRI mode 420, one or more sensors are deactivated or the inputs fromthose sensors are ignored. In various embodiments, the sensors arecontrolled by sensor module 340. While in MRI mode 420, a personoperating the MRI scanner monitors the patient for potential distress.If the operator determines that the patient is in distress, then theoperator stops the MRI scan and uses external device 410 to transmit astat therapy command to the IMD. The stat therapy command indicates theneed for immediate therapy from the IMD device. According to variousembodiments, external device 410 can be, but is not limited to, aprogrammer, a device communicator, an MRI communicator, an MRI partner,a personal computer with a telemetry device, an MRI scanner controllerwith a telemetry device, or other devices known to those of ordinaryskill in the art.

A device communicator, for example, can be an external device that linksimplanted devices with one or more patient management systems. Accordingto some embodiments, the device communicator is an electronic devicethat uses RF to interrogate the implanted PG on either a scheduled basisor ad hoc basis and then transmits the retrieved information to thepatient management system that collects, processes and reports on theretrieved information to physicians.

The stat therapy command is then validated in some embodiments, and theIMD enters the MRI mode stat therapy state 430. In accordance withvarious embodiments, MRI mode stat therapy state 430 changes the stateof one or more sensors or sensory systems. For example, in someembodiments, sensing is turned on and a determination is made if atachyarrhythmia is present through the use of the sensors. If notachyarrhythmia is determined to be present, no therapy is delivered andthe state control module 370 returns the IMD to MRI mode 420.

If a tachyarrhythmia is determined to be present and theantitachyarrhythmia pacing (ATP) has not been exhausted, the statecontrol module 370 will cause the IMD to enter the ATP delivery mode440. In ATP delivery mode 440, single chamber ventricular demand (VVI)pacing can pace the heart until the pacing captures the heart. Once thepacing captures the heart, the IMD slows the pacing rate gradually. Ifthis pacing does not capture the heart then, at such point, the patientis removed from the MRI scanner allowing the patient to receive shockingtherapy from the IMD. Embodiments can provide other types of pacingtherapy such as dual chamber pacing therapy.

When the pacing therapy session is complete, state control module 370returns the IMD to the MRI mode stat therapy state 430. A determinationis made as to whether the tachyarrhythmia still exists and the ATPtherapy has not been exhausted. If the tachyarrhythmia is still presentand the ATP therapy has not been exhausted the control module 370 willcause the IMD to enter the ATP delivery mode 440 again to provideanother ATP therapy session to the patient. This process continues untilthe ATP sessions are exhausted, or until the tachyarrhythmia is nolonger determined to be present. If a determination is made that thesessions are exhausted, then the state control module 370 will cause theIMD to remain in MRI mode stat therapy state 430.

According to some embodiments, while in the MRI mode stat therapy state430, the IMD monitors for an MRI signal and/or a core saturation signalthat indicates that the patient is no longer within the field of theMRI. When one of these signals is detected, the state control module 370will cause the IMD to enter the normal operation mode 450. While in thenormal operation mode 450, the IMD returns to full normal operation. Ifthe arrhythmia still exists, the system can be configured to carry outall of its prescribed operations, including defibrillation shocks ifprogrammed, to treat the arrhythmia by entering tachy therapy state 460.

In accordance with various embodiments, the tachy therapy state 460 canoperate in a variety of different ways. For example, if atachyarrhythmia episode remains from the MRI mode stat therapy state,the next therapy session can be a shock. In other cases, if thearrhythmia episode was successfully terminated after MRI mode stattherapy state 430 was exited, the next tachyarrhythmia therapy will bethe programmed therapy.

According to various embodiments, tachyarrhythmia detection is restoredwhen the patient is observed to be in distress. The MRI tech or operatorterminates the MRI scan, causing the RF and gradient magnetic fields tocease. The MRI tech or operator may then send a stat therapy commandfrom the external device to cause the IMD to enter the stat therapymode. If the stat therapy command is sent, the IMD then enables thesensors and uses existing tachyarrhythmia detection to determine if anarrhythmia exists and if so, provides ATP and WI pacing therapies, forexample. As such, inadvertent stat therapy selection is benign to thepatient since if no tachyarrhythmia is detected, no therapy will beapplied.

FIG. 5 is a flow chart 500 illustrating exemplary operations of animplantable medical device in the presence of an MRI environmentaccording to some embodiments. According to various embodiments, the IMDis performing normal mode operations 510 with full IMD functionality.While in normal mode operations 510, the IMD is also performingmonitoring operation 515 which monitors for an MRI activation signal. Ifno MRI activation signal is found, then MRI activation decision block520 leaves the IMD in the normal mode operations 510. If, however, anactivation signal is found at decision block 520, the IMD branches toenter MRI mode operation 525, which causes the IMD to enter the MRImode.

In some embodiments, during MRI mode operation 525, the IMD monitors fora stat therapy command signal which originates from an external device.If during therapy command decision 530, no stat therapy command signalhas been received, the IMD remains in MRI mode operation 525. If a stattherapy command signal has been received, therapy command decision 530branches to enter the MRI mode stat therapy state 535. Tachyarrhythmiadetermination operation 540 then determines if a tachyarrhythmiacondition exists using one or more IMD sensors.

At condition decision 545, if no tachyarrhythmia is present, the IMDreturns to the MRI mode operation 525 in some embodiments. If atachyarrhythmia is determined to be present, condition decision 545branches to enter ATP delivery mode operation 550 where ATP pacingtherapy is delivered. Once the pacing therapy is completed, the IMDenters MRI mode stat therapy state operation 555, causing the IMD toenter MRI mode stat therapy state. In addition, the IMD monitors forchanges in a core saturation signal which indicates the presence of anMRI field. In some embodiments, the core saturation signal will onlychange after a fixed period (e.g., three seconds) of a detected changein the magnetic fields.

Core saturation decision 560 determines if the core saturation signalindicates the absence of an MRI field. If not, the IMD returns to MRImode stat therapy state operation 555. If the core saturation signalindicates the absence of an MRI field, core saturation decision 560branches to enter normal mode operation 565 which returns the IMD tonormal operations.

Embodiments of the present invention may be provided as a computerprogram product which may include a machine-readable medium havingstored thereon instructions which may be used to program a computer (orother electronic device) to perform a process. The machine-readablemedium may include, but is not limited to, floppy diskettes, opticaldisks, compact disc read-only memories (CD-ROMs), and magneto-opticaldisks, ROMs, random access memories (RAMs), erasable programmableread-only memories (EPROMs), electrically erasable programmableread-only memories (EEPROMs), magnetic or optical cards, flash memory,or other type of media/machine-readable medium suitable for storingelectronic instructions. Moreover, embodiments of the present inventionmay also be downloaded as a computer program product, wherein theprogram may be transferred from a remote computer to a requestingcomputer by way of data signals embodied in a carrier wave or otherpropagation medium via a communication link (e.g., a modem or networkconnection).

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

What is claimed is:
 1. A method for operating an implantable medicaldevice (IMD) implanted within a patient in the presence of a magneticresonance imaging (MRI) environment, the method comprising: receiving atherapy command from an external device while the IMD is in the presenceof an MRI electromagnetic field and is operating in a first operationalmode in which one or more sensors of the IMD have been disabled, thetherapy command configured to prompt the IMD to provide immediatetherapy to the patient while in the MRI electromagnetic field; andplacing the IMD in a second operational mode upon receiving the therapycommand, wherein the second operational mode includes: enabling the oneor more sensors of the IMD; determining whether an arrhythmia is presentusing the one or more sensors; and delivering a first therapy to thepatient if the arrhythmia is determined to be present, wherein a secondtherapy is not delivered by the IMD when in the second operational modeif the arrhythmia is determined to be present while the IMD is in thepresence of the MRI electromagnetic field.
 2. The method of claim 1,wherein the second operational mode further comprises: determining ifthe first therapy has been exhausted and if the arrhythmia is stillpresent; and delivering a further regimen of the first therapy if thefirst therapy has not been exhausted and the arrhythmia is determined tostill be present.
 3. The method of claim 1, further comprising:monitoring for a core saturation signal that indicates the absence orpresence of an MRI electromagnetic field that would result in aninability of the IMD to deliver the second therapy; and placing the IMDin a third operational mode when the core saturation signal beingmonitored indicates the absence of the MRI electromagnetic field,wherein in the third operational mode the IMD is configured to determineif either the first therapy or the second therapy is needed and todeliver the first therapy or the second therapy when a determination ismade that the first therapy or the second therapy is needed.
 4. Themethod of claim 1, further comprising: monitoring a core saturationsignal that indicates the absence of external magnetic fields that wouldinterfere with the second therapy delivered by the IMD; if the coresaturation signal indicates the absence of the external magnetic fields,placing the IMD in a third operational mode in which the second therapyis delivered if the arrhythmia is determined to be present.
 5. Themethod of claim 1, wherein the second therapy utilizes a high voltagecapacitor, and proper function of the high voltage capacitor iscompromised by the MRI electromagnetic field.
 6. The method of claim 1,wherein the IMD delivers neither the first therapy nor the secondtherapy to the patient if the arrhythmia is not sensed by the one ormore sensors.
 7. The method of claim 1, wherein the command is receivedfrom an operator via an external device.
 8. The method of claim 1,wherein the one or more sensors have been disabled by eitherdeactivating the one or more sensors or the output from the one or moresensors is being ignored by the IMD, and wherein enabling the one ormore sensors of the IMD includes activating a deactivated sensor ormonitoring the output from the one or more sensors that is beingignored.
 9. An implantable medical device (IMD) configured forimplantation in a patient to monitor cardiac activity in, and delivertherapy to, the patient's heart, the IMD comprising: a pulse generatoroperable to deliver a first therapy; and a state control module operableto selectively place the IMD in any of a plurality of operational modesfor operation of the IMD in the presence of an MRI electromagnetic fieldthat is strong enough to interfere with operation of the IMD, whereinthe IMD is configured to not deliver the second therapy while in thepresence of the MRI electromagnetic field and the operational modesinclude: a first operational mode where the IMD monitors for a therapycommand from an external device indicating the need for immediatetherapy, wherein the IMD is configured to not deliver the first therapywhile in the first operational mode, a second operational mode thatactivates one or more sensors to be used in determining the presence ofan arrhythmia, wherein the IMD is configured to enter the secondoperational mode based on reception of the therapy command while in thefirst operational mode, and a third operational mode in which the IMDdelivers the first therapy, wherein the IMD is configured to enter thethird operational mode based on detecting the presence of the arrhythmiain the second operational mode.
 10. The IMD of claim 9, furthercomprising a communication module operable to receive mode commands froma device external to the patient, wherein the mode commands prompt theIMD to enter into the plurality of operational modes.
 11. The IMD ofclaim 10, wherein the communication module includes circuitry forcommunicating wirelessly with the device external to the patient. 12.The IMD of claim 9, wherein the state control module is operable toplace the IMD in a fourth operational mode while not in the presence ofthe MRI electromagnetic field, the IMD configured to monitor for thearrhythmia and deliver a second therapy based on detection of thearrhythmia while in the fourth operational mode.
 13. The IMD of claim12, wherein the IMD includes a communication module to receive andprocess command signals from the external device, and wherein the IMD isconfigured to transition from the fourth operational mode to the firstoperational mode after a first operational mode command signal isreceived.
 14. The IMD of claim 12, wherein the IMD further includes anMRI detection module configured to automatically detect the presence ofthe MRI electromagnetic field, and wherein, in response to the detectionof the MRI electromagnetic field, the state control module is configuredto place the IMD in the first operational mode.
 15. The IMD of claim 12,wherein the IMD comprises a high voltage capacitor, the second therapyutilizes the high voltage capacitor of the IMD, and proper function ofthe high voltage capacitor is compromised by the MRI electromagneticfield.
 16. A method of operating an implantable medical device (IMD) inthe presence of a magnetic resonance imaging (MRI) environment, themethod comprising: monitoring for a signal indicating the presence of astrong MRI electromagnetic field that could interfere with operation ofthe IMD; entering a first operational mode when the signal is detected,wherein upon entering the first operational mode of the IMD at least onesensor input to the IMD is ignored and no stimulation therapy isdelivered to a patient's heart by the IMD; monitoring for a therapycommand signal from an external device indicating the need for immediatetherapy while the IMD is still in the presence of the MRIelectromagnetic field and in the first operational mode; transitioningthe IMD into a second operational mode upon detecting the therapycommand signal while the IMD is still in the presence of the MRIelectromagnetic field, wherein the at least one sensor input of the IMDis monitored to determine if an arrhythmia exists while the IMD is inthe second operational mode; and while the IMD is still in the secondoperational mode, delivering a first therapy to the patient if thearrhythmia is determined to be present while the IMD is still in thepresence of the MRI electromagnetic field, wherein a second therapy isnot delivered by the IMD if the arrhythmia is determined to be presentwhile the IMD is still in the presence of the MRI electromagnetic field.17. The method of claim 16, wherein the MRI signal is received from anexternal device.
 18. The method of claim 16, wherein upon entering intothe second operational mode, the method further comprises: monitoringfor a core saturation signal which indicates a continued presence of theMRI electromagnetic field; and wherein delivering the first therapy tothe patient includes delivering up to a fixed number of therapy sessionsif the arrhythmia is determined to exist and the core saturation signalindicates the presence of the MRI electromagnetic field.
 19. The methodof claim 18, wherein once the core saturation signal indicates anabsence of the MRI electromagnetic field, the method further comprisesentering a third operational mode that allows the IMD to provide thesecond therapy to the patient.
 20. The method of claim 19, wherein thesecond therapy utilizes a high voltage capacitor, and proper function ofthe high voltage capacitor is compromised by the MRI electromagneticfield.